US LNG exports surge but will buyers in China turn up?
CAMBRIDGE, Mass. - KalVista Pharmaceuticals (NASDAQ:KALV), a clinical-stage biotech company with a market capitalization of $644 million that has seen its stock surge 45% over the past six months, presented new data showing its investigational oral medication sebetralstat effectively treats hereditary angioedema (HAE) attacks in patients already receiving long-term prophylaxis (LTP) therapy, according to findings unveiled at the European Academy of Allergy and Clinical Immunology Congress. InvestingPro data shows 7 analysts have recently revised their earnings expectations upward for the upcoming period.
The interim analysis from the KONFIDENT-S study involved 35 participants who treated 382 HAE attacks with sebetralstat while receiving various prophylactic treatments. Patients began treatment quickly after symptom onset, with a median time of 6 minutes, and experienced beginning of symptom relief at a median of 1.3 hours.
A separate study presented at the congress revealed challenges with LTP adherence, with less than half (44%) of HAE patients adhering to their prophylactic treatment regimens over a 12-month period. More than 20% discontinued their LTP therapy entirely during this timeframe.
"Even with advancements in HAE long-term prophylactic treatments, attacks still occur, highlighting the critical need for easily administered, fast-acting, effective on-demand options," said Dr. Marc Riedl, Professor of Medicine at the University of California, San Diego, in the press release.
Sebetralstat is currently under regulatory review by the FDA as the first potential oral, on-demand treatment for HAE in individuals aged 12 and older. The company has also submitted marketing authorization applications to the European Medicines Agency and other global regulatory authorities.
The data was presented at the EAACI Congress 2025 in Glasgow, United Kingdom.
In other recent news, KalVista Pharmaceuticals has encountered a delay in the FDA’s decision on its lead drug candidate, sebetralstat, an oral treatment for hereditary angioedema (HAE). The FDA cited resource constraints as the reason for not meeting the June 17 review deadline, but expects to deliver a decision within four weeks. Despite this delay, the FDA has not requested additional data or studies, nor raised concerns about the drug’s safety or efficacy. KalVista also announced a licensing agreement with Kaken Pharmaceutical to commercialize sebetralstat in Japan, securing an upfront payment of $11 million with potential for additional payments upon regulatory approval. Meanwhile, JMP Securities has reiterated its Market Outperform rating and $19 price target for KalVista, expressing confidence in the drug’s approvability based on clinical data. Stifel analysts maintained their Buy rating and $39 price target, highlighting the drug’s strong efficacy and the commercial opportunity in the on-demand HAE treatment market. The company is actively preparing for sebetralstat’s launch, with regulatory applications pending in multiple countries. These developments reflect KalVista’s strategic efforts to expand the global reach of sebetralstat amid ongoing regulatory reviews.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.